^
    Back
    Association details:
    Biomarker:BRAF V600
    Cancer:Melanoma
    Drug:Mekinist (trametinib) (MEK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    06/30/2014
    Excerpt:
    Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    Therapeutic Goods Administration
    Excerpt:
    MEKINIST as a monotherapy is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma and in whom either there is intolerance to BRAF inhibitors or BRAF inhibitors cannot be used.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A study of GSK1120212 compared with chemotherapy in patients with BRAF mutation positive advanced or metastatic melanoma

    Excerpt:
    ...Histologically confirmed, Stage III unresectable (Stage IIIc) or metastatic (Stage IV) cutaneous melanoma which is also determined to be BRAF V600E/K mutation-positive by the central laboratory. ...
    Trial ID:
    2010-022838-85
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Trametinib in Advanced Cancer Patients With Hepatic Dysfunction

    Excerpt:
    ...- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which standard curative or palliative treatments do Excludes: Pancreatic cancer patients, colorectal cancer patients, or BRAF V600E melanoma patients who have failed BRAF inhibitors - Must have completed any prior treatments 28 days or more before study entry. ...
    Trial ID:
    NCT02007382
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and in Combination With Trametinib in Subjects With BRAF V600 Mutant Solid Tumors

    Excerpt:
    ...Subject has documented evidence of a BRAF V600 mutation obtained from tumor tissue or liquid biopsy: (other protocol conditions may apply) 5....
    Trial ID:
    NCT05668585